In the manufacturing and processing of many different products, it often is necessary to transfer fluid into or out of a closed processing system and do so in a substantially aseptic, hygienic, or sterile manner without breaching the closed nature of the system. In particular, the need to transfer fluid often arises in the manufacturing and processing of pharmaceuticals, biopharmaceuticals, or other biotechnology applications where processes are conducted in large process tanks, including but not limited to, the transfer of media solutions. The need for fluid transfer arises in other applications and industries as well, including but not limited to, the production of food, cosmetics, paint, chemicals, including hazardous chemicals, and the transfer and handling of semiconductor fluids.
Regardless of the industry, during transfers or sampling the fluid in tanks or other vessels must remain substantially free of contaminants. In addition, when making such transfers, it is desirable to keep the environment surrounding a vessel free from contamination by the contents of the vessel or a sample taken therefrom. It is often the case that throughout the manufacturing process there is a need to take multiple samples from the fluid or, in some circumstances, add additional fluid or media to the fluid in a vessel. To accomplish a substantially aseptic, hygienic, or sterile transfer, it is desirable to control the environment through which the fluid flows, for example, the pathway from a tank to a sample container should be substantially aseptic, hygienic, or sterile along the entire pathway. Furthermore, it is desirable that the fluid transfer device be safe for use, reliable, and of low-cost construction.
It is also desirable to transfer fluid using a device which is pre-sterilized and disposable. A pre-sterilized device avoids the need for an operator to prepare the device for use. In addition, a disposable device avoids the time consuming and laborious task of sterilizing sampling equipment. Further, such sterilization can damage the fluid transfer device and render it useless before its first use.
Pre-sterilized sampling devices that allow for substantially aseptic transfers are disclosed in pending PCT Application No. PCT/US2008/070482, owned by the assignee of the present invention, the entire contents of which are hereby incorporated by reference.
In some instances there arises the need to transfer a media solution having a high particulate content, that contains particles, or is of high viscosity. These media solutions may clog a cannula or hypodermic needle found in some fluid transfer devices. Devices that utilize a hypodermic needle or cannula, like that disclosed in PCT Application No. PCT/US2008/070482, may clog if particles or a media solution with a high particulate concentration or viscosity is transferred through the device. Such media solutions necessitate larger openings to accommodate particulates or increased viscosity without clogging the transfer device. One sampling device that is capable of transferring fluids with particulates is disclosed in U.S. Pat. No. 7,293,477. However, that device lacks a substantially aseptic, hygienic or sterile cavity in the fluid transfer device that ensures that the fluid in the vessel from which a sample may be drawn remains substantially free of contaminants while, at the same time, ensuring that the environment surrounding a vessel remains free from contamination by the contents of the sample.
In addition, there arises the need to transfer media solutions containing cells, live cultures, or proteins. Such media solutions require low sheer or physical forces to avoid damage to the solution's content during a transfer. Devices using a cannula or hypodermic needle may cause such damage.
In view of the above, there exists a need for a fluid transfer device that is inexpensive, pre-sterilized, disposable, capable of being used with standard industrial ports commonly found in fluid receptacles, and capable of use in common industrial settings, such as those found in the pharmaceutical, biopharmaceutical, or other high purity industries, where there is often the need to transfer fluids with particles or high particulate concentrations.